UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia
Acronym	Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia
Scientific Title	Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia
Scientific Title:Acronym	Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia
Region	Japan

Condition
Condition	advanced squamous cell lung cancer with idiopathic interstitial pneumonia
Classification by specialty	Pneumology Hematology and clinical oncology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety and the efficacy of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	response rate
Key secondary outcomes	OS: overall survival PFS: progression free survival TTF: Time to treatment failure toxicity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Carboplatin AUC = 5 , day1 Paclitaxel 70mg/m2, day1,8,15 4-6 cycle
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Squamous cell lung cancer 2) Age over twenty 3) Idiopathic interstitial pneumonia 4) Measurable lesion 5) ECOG performance status 0 or 1 6) Adequate organ function WBC>=3000/mm3 and neutrophil count >=2000/mm3 Hgb>=10.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL 7) PaO2>=60.0 torr or SpO2>=92.0 %( room air) 8) No symptoms from brain metastasis 9) Life expectancy > 3 months 10) Written informed consent
Key exclusion criteria	1) Secondly interstitial pneumonia. 2) History of acute exacerbation of interstitial pneumonia within 3 months. 3) Subacute progression of interstitial pneumonia within 3 months. 4) Using prednisolone or immune-suppressive agent. 5) Need to home oxygen therapy. 6) Past history of severe drug allergy. 7) Active infectious disease. 8) Severe complications 9) Symptomatic brain metastasis. 10) Uncontrollable effusion. 11) Active combined malignancy 12) Any ineligible case judged by physician.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuyuki Katakami
Organization	Institute of Biomedical Research and Innovation Hospital
Division name	Division of Integrated Oncology
Zip code
Address	2-2, Minatojima Minamimachi Chuo-ku, Kobe 650-0047, Japan
TEL	078-304-5200
Email	katakami@fbri.org

Public contact
Name of contact person	1st name Middle name Last name Hidekazu Suzuki
Organization	Osaka Preferctural Medical Center for Respiratory and Allegic Diseases
Division name	Thoracic Oncology
Zip code
Address	3-7-1 Habikino Habikino-shi Osaka 583-8588 Japan
TEL	072-957-2121
Homepage URL
Email	suzukih@opho.jp

Sponsor
Institute	IP lung cancer study group
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 11 Month 21 Day
Date of IRB	2012 Year 10 Month 13 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 08 Day
Last modified on	2022 Year 03 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021119